Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0650

+0.2%

Nov 18 12:36 PM EST

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To: LT2011 who wrote (11967)	5/23/2013 7:06:30 AM
From: NTTG	1 Recommendation Read Replies (1) of 13111

They took a big step backward when stage IV and nodal stage III patients were excluded from further consideration after FDA review of the PII data; and when they disclosed that future planing for HCC trials would have to include a systemic therapy, PV-10 alone would not be allowed. Two good aspects of the limited patient scope for MM are: 1) the proposed number of study subjects fell from ~320 to ~180, which should ease enrollment constraints some: inclusion screening will need to be very specific to make sure they get the right patients [in the PI HCC trial 1/6 enrolled patients did not meet the original histologic staging criteria], and 2) data variability around the mean will be tighter, making statistical analysis easier if a real benefit is present. They are now standing on a slippery rock in the middle of a rain swollen river.... they know the forward step they have to take (get the dosing right for MM trial) but the river bank is far away (HR goal) and they could easily slip and drowned if the FDA limits the amount or number of visible lesions that can be treated. Their progress at this point is limited to the fact that they are still standing on the rock. Even if you thought a big pharma rescue service was on the way, it is not clear when they will arrive. Since we do not know the finalized PV-10 dosing schedule, I can not guestimate the likely success of a PIII trial designed with a head to head comparison of IL PV-10 to a systemic Tx in stage IIIb and IIIc patients using a primary outcome of progression free survival. My recent reading of mouse data that includes limited drug comparisons is not encouraging, but I could also see a 'rolling enrollment' strategy that might mitigate some of the dosing concerns (although I think they would need more than the proposed 180 patients for that) What we do know is that this is the clarion moment for PVCT; the PIII trial design and resulting data shape the final approval language for use. Anything they want (i.e. specific claim of a bystander effect as a product differentiating feature) but do not get solidly into the proposed PIII trial will be very difficult to add later, and certainly does not attract the attention of rescuers. They think the recent mouse data offers a smaller rock closer to shore that they might try for, but it is just below the surface of the churning water and covered in slimy moss....tricky move. Needless to say, the afternoon sun is starting to dip into the mountain tops and hungry black bears can be heard in the distance.........

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